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NCT Number: NCT06738771

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

The primary objective of the ADDICT study is to assess and compare the clinical efficacy of available options for antimicrobial therapy (new beta-lactam/beta-lactamase inhibitor combination, cefiderocol or older agents such as aminoglycosides and colistin) in unselected patients with infection due to difficult-to-treat P. aeruginosa.

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Key information

Conditions

Pseudomonas Infections Antibacterial Agents Bacterial Infections Bacterial Infections and Mycoses Beta-lactam Antibiotics Drug Resistance, Multiple, Bacterial Gram-Negative Bacterial Infections Infections Prognosis Pseudomonas Aeruginosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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About this study

Infections due to Pseudomonas aeruginosa isolates with acquired resistances to all first-line antipseudomonal beta-lactams and fluoroquinolones (difficult-to-treat isolates - DTR), pose serious therapeutical challenges, especially in critically ill and/or immunocompromised patients. Certain new beta-lactam/beta-lactamase inhibitor combinations (BL/BLI (beta lactamine/ beta lactamase inhibitor) - i.e., ceftolozane-tazobactam, ceftazidime-avibactam, imipenem-relebactam, others) and cefiderocol have shown promising results for the treatment of infections due to DTR P. aeruginosa. However, multicenter data on their real-life utilization in this indication are still scarce.

The ADDICT study is a prospective, multicenter cohort study including unselected patients with DTR P. aeruginosa infection requiring definite intravenous antimicrobial therapy. The primary objective of the study is to investigate the clinical efficacy of available options (new BL/BLI, cefiderocol or older agents such as aminoglycosides and colistin) in this population. Secondary objectives are to compare the clinical and microbiological efficacy of available options in infections due to DTR P. aeruginosa with in vitro susceptibility to more than one last-resort drug, to compare the incidence of non-ecological adverse events observed with these drugs, to assess the incidence of resistance emergence under therapy and to elucidate the molecular mechanisms of resistance emergence, to assess the benefits and risks of combination therapy in this indication, to compare the acquisition rates of multidrug-resistant bacteria other than DTR P. aeruginosa, and Clostridioides difficile infection, to compare Day-28 and in-hospital all-cause mortality rates.

Patients will be recruited in 60 hospital centers contributing to four French networks of research in infectious diseases and critical care (CRICS-TRIGGERSEP, ReaRezo, OutcomeRéa, RENARCI - PROMISE metanetwork). Clinical variables will be collected through an electronic case-report form. DTR P. aeruginosa isolates will be sent to the National Reference Center of Antimicrobial Resistance in P. aeruginosa for centralized analyses (extended antimicrobial susceptibility testing, MLST, whole-genome sequencing of successive isolates if resistance emergence under therapy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients aged 18 or over and requiring intravenous definite antimicrobial therapy for a DTR P. aeruginosa infection

Exclusion criteria

  • Cystic fibrosis
  • P. aeruginosa DTR colonization or P. aeruginosa DTR infection not requiring definitive intravenous antibiotic therapy
  • Protected person (under guardianship or curatorship)
  • Persons under court protection
  • Persons deprived of liberty
  • Opposition expressed for participation in the study

Treatment and study plan

Primary outcomes

  1. Clinical cure rate

    Time frame: Test of cure visit

    Clinical responses will be assessed by local investigators. Clinical cure will be defined as a composite endpoint of survival with no relapse occurring since the end of definite therapy and the complete resolution of all initial clinical signs of infection at the ToC visit (all-cause deaths at the ToC visit will be considered as clinical failures).

  2. Clinical cure

    Time frame: Day 7±2 after the completion of definite therapy

    Clinical responses will be assessed by local investigators. Clinical cure will be defined as a composite endpoint of survival with no relapse occurring since the end of definite therapy and the complete resolution of all initial clinical signs of infection at the ToC visit (all-cause deaths at the ToC visit will be considered as clinical failures).

Secondary outcomes

  1. Microbiological eradication

    Time frame: Day 7

    Negativation of cultures for DTR P. aeruginosa in participants with at least one collected follow-up bacteriological sample (when clinically indicated) before the ToC visit

  2. Resistance emergence

    Time frame: Up to hospital discharge, an average of 1 month

    Any culture growing a DTR P. aeruginosa isolate with resistance to at least one new antimicrobial agent (compared to the first isolate) between the second day of definite therapy and hospital discharge

  3. Non-ecological adverse events

    Time frame: At test-of-cure visit, 7±2 days after the completion of definite therapy

    Any toxicity or allergic reaction attributed to the antimicrobial agent by the local investigator

  4. Non-ecological adverse events

    Time frame: From the first day of definite therapy to the ToC visit

    Any toxicity or allergic reaction attributed to the antimicrobial agent by the local investigator

  5. Acquisition of multidrug-resistant bacteria other than DTR P. aeruginosa

    Time frame: Up to hospital discharge, an average of 1 month

    Culture of any clinical or surveillance sample growing a multidrug-resistant bacteria other than P. aeruginosa

  6. Clostridioides difficile infection

    Time frame: Up to hospital discharge, an average of 1 month

    Documented C. difficile infection

  7. In-hospital death

    Time frame: Up to hospital discharge, an average of 1 month

    All-cause death

  8. Death at Day 28

    Time frame: Day 28

    All-cause death

Study contacts

Contact information is provided by the study sponsor or research team.

FRANCOIS BARBIER, Professor

CONTACT

[email protected]

+33238229939

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Antimicrobial Therapy for Infections Due to Pseudomonas Aeruginosa With Difficult-to-treat Resistance: a Real-world, Prospective, Multicenter Cohort Study

Acronym: ADDICT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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